Regulatory Affairs Specialist／薬事スペシャリスト

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Date: Jun 11, 2025

Location: Chuo-ku, Tokyo, JP, 104-0061

Company: Dentsply Sirona, Inc

 

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

 

Bringing out the best in people

 

As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us.

 

Working at Dentsply Sirona you are able to:

 

Develop faster - with our commitment to the best professional development.

 

Perform better - as part of a high-performance, empowering culture.

 

Shape an industry - with a market leader that continues to drive innovation.

 

Make a difference -by helping improve oral health worldwide.  

 

 

Position responsible for pharmaceutical affairs applications for our products and related pharmaceutical affairs operations.

Perform pharmaceutical affairs applications for dental products (equipment, dental materials, implants, etc.).

 

• As part of the pharmaceutical affairs department, have knowledge and understanding of the Pharmaceutical Affairs and Medical Devices Act.

• Obtain manufacturing and marketing approval and certification for medical devices (Class I to III), and handle changes and notifications.

• Manage business operations under the Pharmaceutical and Medical Device Act, including manufacturing facility registration.

• Prepare and submit applications for insurance coverage.

 

<Main Communication Partners>

Headquarters (Europe, Americas) Design, Development, Quality Assurance, and Marketing Department personnel

Our Sales Department, Marketing, and Service Department personnel

 

 

当社製品の薬事申請及びそれに付随する薬事関連実務業務を行うポジション。
歯科用製品(機器類、歯科材料、インプラント等)に関して薬事申請実務を行う。

・薬事部門として、医薬品医療機器等法に対して認識・理解を持つ。
・医療機器（クラスⅠ~Ⅲ）の製造販売承認、認証の取得、並びに変更事項の対応、届出を行う。
・製造所登録等の医薬品医療機器等法下での業態管理を行う。
・保険適用希望書の作成提出。

＜主なコミュニケーション先＞
本社（欧州・米州）設計、開発、品質保証、マーケティング部門担当者
当社営業部門、マーケティング、サービス部門担当者

 

 

Dentsply Sirona is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.

Dentsply Sirona Canada welcomes and encourages applications from all backgrounds, including individuals with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

If you need assistance with completing the online application due to a disability, please send an accommodation request to careers@dentsplysirona.com. Please be sure to include “Accommodation Request” in the subject.